NCGC00024964-02 | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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NCGC00024964-02
South Africa

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Fulvestrant

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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pharmacompass-2-m-2025-11-03

NCGC00024964-02

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 13 USDMF, 10 CEP/COS, 4 JDMF, 5 EU WC, 8 KDMF, 11 NDC API, 25 Listed Suppliers, $ API Reference Price

45 API Suppliers
13 USDMF
10 CEP/COS
4 JDMF
5 EU WC
8 KDMF
11 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

284 Drugs in Development

284 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

94 FDF Dossiers, 19 FDA Orange Book, 42 Europe, 5 Canada, 5 Australia, 8 South Africa, 15 Listed Dossiers

94 FDF Dossiers
19 FDA Orange Book
42 Europe
5 Canada
5 Australia
8 South Africa
15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAMUSCULAR - 125MG/2.5ML (50MG/ML), SOLUTION;INTRAMUSCULAR - 250MG/5ML (50MG/ML)

SOLUTION;INTRAMUSCULAR - 125MG/2.5ML (50MG/ML)
SOLUTION;INTRAMUSCULAR - 250MG/5ML (50MG/ML)

RELATED EXCIPIENT COMPANIES

2 Nanjing Well Pharmaceutical, 1 Actylis, 2 Finar, 1 Symrise, 1 TopChem Pharmaceuticals

2 Nanjing Well Pharmaceutical
1 Actylis
2 Finar
1 Symrise
1 TopChem Pharmaceuticals

EXCIPIENTS BY APPLICATIONS

4 Topical, 3 Parenteral, 1 Solubilizers

4 Topical
3 Parenteral
1 Solubilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 111 News #PharmaBuzz

2 Data Compilation #PharmaFlow
111 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 10 Annual Reports

16 US Medicaid Prescriptions
4 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

6 APIs, 8 FDF Dossiers

6 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents, 1 Health Canada Patents

3 US Patents
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 4 Others

2 EDQM
3 USP
4 Others

$ API Ref.Price (USD/KG) : 40,457 Xls

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8 All

01 1Dr Reddy's Laboratories (Pty) Ltd

02 1Accord Healthcare (Pty) Ltd

03 2Astrazeneca Pharmaceuticals (Pty) Ltd

04 1Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

05 1Juno Pharma SA (Pty) Ltd

06 1Mylan (Pty) Ltd

07 1Teva Pharmaceuticals (Pty) Ltd

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8 All

01 1FULVESTRANT

02 7Fulvestrant

filter Dosage Form Reset all filters

8 All

01 3INJ

02 5PFS

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8 All

01 1Eranfu 250

02 1FASTELEV

03 2Faslodex

04 1Frexivo

05 1Fuldexa

06 1Fulvedex 250mg/5ml

07 1Fulvestrant Mylan

Minakem Fulvestrant

List of Suppliers

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01

Dr Reddy's Laboratories (Pty) Ltd

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fulvestrant

Brand Name : Eranfu 250

Dosage Form : PFS

Dosage Strength : 250mg/5ml

Packaging : 5X2mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Dr Reddy Company Banner

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02

Accord Healthcare (Pty) Ltd

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Accord Healthcare (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fulvestrant

Brand Name : Fuldexa

Dosage Form : PFS

Dosage Strength : 250mg/5ml

Packaging : 5X2mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

CTAD25

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Astrazeneca Pharmaceuticals (Pty) Ltd- B...

CTAD25

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Fulvestrant

Brand Name : Faslodex

Dosage Form : INJ

Dosage Strength : 250mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Astrazeneca Pharmaceuticals (Pty) Ltd

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Astrazeneca Pharmaceuticals (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fulvestrant

Brand Name : Faslodex

Dosage Form : INJ

Dosage Strength : 250mg/5ml

Packaging : 5X2mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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05

Astrazeneca Pharmaceuticals (Pty) Ltd

CTAD25

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Astrazeneca Pharmaceuticals (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fulvestrant

Brand Name : Frexivo

Dosage Form : INJ

Dosage Strength : 250mg/5ml

Packaging : 5X2mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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06

Juno Pharma SA (Pty) Ltd

CTAD25

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Juno Pharma SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fulvestrant

Brand Name : Fulvedex 250mg/5ml

Dosage Form : PFS

Dosage Strength : 250mg/5ml

Packaging : 5X2mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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07

Teva Pharmaceuticals (Pty) Ltd

CTAD25

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

CTAD25

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

FULVESTRANT

Brand Name : FASTELEV

Dosage Form : PFS

Dosage Strength : 250MG/5ML

Packaging : 5X2MG/5ML

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Mylan (Pty) Ltd

CTAD25

Not Confirmed

Mylan (Pty) Ltd

CTAD25

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fulvestrant

Brand Name : Fulvestrant Mylan

Dosage Form : PFS

Dosage Strength : 250mg/5ml

Packaging : 5X2mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Digital Content

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